Acute Myeloid Leukemia, Myelodysplastic Syndrome
Conditions
Keywords
Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia, Myelodysplastic syndrome, Acute myeloid leukemia
Brief summary
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
Interventions
DRUGAra-C
Induction: 3000mg/m2 IV infusion for day 1 and day 5 Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total)
DRUGMitoxantrone
Induction: 30mg/m2 after the end of HiDAC day 1 and day 5
DRUGEtoposide
Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis. * Patients must have t-MDS/t-AML * To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible. * Patients must be over the age of 10. * Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology.
Exclusion criteria
* Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection) * Psychiatric condition which would prevent compliance or possibly be worsened by treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to Induction Chemotherapy (CR or PR) | Day 28-40 | Complete remission (CR): \<5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): \>5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made |
| Overall Survival | Up to 2000 days | — |
| Relapse-free Survival | Up to 2000 days | Relapse is defined as bone marrow blasts \>5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Stem Cell Collection | 1-5 days from initiation of stem cell collection | Feasibility is the ability to cryopreserve \>=2.0 x 10\^6 CD34+ cells/kg |
| Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant | Up to 883 days | — |
| Numbers of Stem Cells Collected | 1-5 days from initiation of stem cell collection | — |
| Overall Survival in Patients Undergoing Autologous Stem Cell Transplant | Up to 817 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients Ara-C Mitoxantrone Etoposide | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enrollment | Desired other therapy/refused | 28 |
| Screening | Not eligible | 56 |
| Stem Cell Mobilization | Count too low (2), sudden death (1) | 3 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 56 years |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 32 |
| serious Total, serious adverse events | 7 / 32 |
Outcome results
Primary
Overall Survival
Time frame: Up to 2000 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Overall Survival | 399 Days |
Primary
Relapse-free Survival
Relapse is defined as bone marrow blasts \>5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.
Time frame: Up to 2000 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Relapse-free Survival | 415 Days |
Primary
Response to Induction Chemotherapy (CR or PR)
Complete remission (CR): \<5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): \>5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made
Time frame: Day 28-40
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Response to Induction Chemotherapy (CR or PR) | 81.2 percentage of participants |
Secondary
Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
Time frame: Up to 883 days
Population: Subset of patients undergoing autologous stem cell transplant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant | 367 Days |
Secondary
Feasibility of Stem Cell Collection
Feasibility is the ability to cryopreserve \>=2.0 x 10\^6 CD34+ cells/kg
Time frame: 1-5 days from initiation of stem cell collection
Population: Subset of patients in CR who underwent mobilization and attempted stem cell collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Feasibility of Stem Cell Collection | 70 percentage of participants |
Secondary
Numbers of Stem Cells Collected
Time frame: 1-5 days from initiation of stem cell collection
Population: Subset of patients in CR who underwent mobilization and attempted stem cell collection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Numbers of Stem Cells Collected | 4.50 10^6 CD34+ cells/kg |
Secondary
Overall Survival in Patients Undergoing Autologous Stem Cell Transplant
Time frame: Up to 817 days
Population: Subset of patients undergoing autologous stem cell transplant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Overall Survival in Patients Undergoing Autologous Stem Cell Transplant | 294 Days |